First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.

Coronary Artery Disease Clinical Trial

Official title:

INCSTENT First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03375411
• Other study ID #: 17-1036
• Status: Withdrawn
• Phase: N/A
• Start date: December 30, 2017
• Est. completion date: January 25, 2019

Study information

• Verified date: October 2022
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.

Description:

The cost of performing a percutaneous coronary intervention is very variable since a large number of materials and human resources are considered, with the Stent cost being a fundamental factor; in developing countries, the cost this technology represents an important expense for the patient and the health system; which promotes the development of local technology to support the requirement of these devices. Ischemic heart disease together with cerebral vascular events is the main cause of, adding 15 million deaths per year. Percutaneous revascularization is the gold standard choice in many of the variants of presentation of ischemic heart disease, the implantation of Stents is the most used method. Nowadays more and more countries start their own research and development of novel devices in order to reduce cost. Research question: Is the INC1 Bare Metal Stent safe and effective for the treatment of de novo coronary lesions in humans? Hypothesis: The INC1 Bare-metal Stent is safe and effective for the treatment of de novo coronary lesions in humans The INC1 Bare metal Stent is a 70uCoCr

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 25, 2019
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Both genders.
• From 18 to 75 years
• Stable ischemic heart disease.
• Live less than 300 km from the Institution
• Single coronary artery disease with a single coronary lesion
• Stenosis of 50 to 90% of the lumen of the vessel to be treated.
• Lesions less than 20 mm long
• Reference lumen of the vessel to be treated greater than 2.5mm and less than 4.5mm

Exclusion Criteria:

• Left main disease.
• Lesions greater than 90% of the lumen.
• Non-dilatable lesion with conventional balloons.
• Contraindication for dual antiplatelet therapy.
• Creatinine clearance less than 45ml / min.
• Calcification from moderate to severe.
• Multivessel coronary artery disease.
• Chronic total occlusion.
• Cardiogenic shock or hemodynamic instability.
• Left ventricular ejection fraction less than 30%.
• Valvular disease of moderate to severe.
• Coronary disease in bifurcation.
• Probable or definite presence of thrombus in the lesion.

Related Conditions & MeSH terms

• Angioplasty
• Angioplasty, Balloon, Coronary
• Coronary Angiography
• Coronary Artery Disease
• Humans
• Stents
• Treatment Outcome

Intervention

Device:
• Stent INC1
Coronary intervention with conventional angioplasty technique but with a novel bare metal stent.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiología	Mexico City

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez	GSE Biomedical, Medstent SA de CV.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of late lumen loss [Safety and Tolerability])	The primary endpoint of the study is angiographic in-stent late lumen loss (LLL), defined as the difference between the post-procedural minimal lumen diameter (MLD) in the stented segment and the MLD in the same segment at follow-up measured by the angiography laboratory.	9 months
Secondary	Need of Revascularization	The Need of Revascularization of the treated vessel with a new angioplasty	9 months
Secondary	MACE	To evaluate the presence of major adverse cardiovascular events such (MACE) as cardiac death, myocardial infarction, new angina event or revascularization through surgery.	9 months
Secondary	Hyperplasia	To evaluate the degree of neointimal hyperplasia or at 9 months by intracoronary ultrasound.	9 months